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OpenTrials
Completed

NCT Number: NCT04612400

Whole Body Protein Metabolism of a Whey/EAA Supplement Using Continuous Oral Stable Isotopes

To evaluate the validity of a continuous oral sip-feeding method of stable isotope tracer for the evaluation of whole-body protein metabolism in response to two different doses of an EAA/whey protein supplement (Low=6.3g and High=12.6g). Results will be compared to those previously determined by constant infusion with the same EAA/whey supplement.

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Key information

Conditions

Healthy

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of Translational Research in Aging and Longevity

Little Rock, Arkansas, 72205, United States

About this study

This will be a double-blinded, randomized, crossover pilot study to evaluate the validity of a continuous oral sip-feeding of stable isotope tracer method for the evaluation of whole-body protein metabolism. This method will be evaluated using two different amounts of an essential amino acid (EAA) + whey protein supplement on up to six younger, healthy subjects. Stable isotope preparations will be continuously consumed by subjects throughout visits 2 and 3 to enable whole body protein metabolism to be measured.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 21-40 years.
  • Body weight of ≤ 80kg.

Exclusion criteria

  • History Chronic kidney disease.
  • History of dairy allergy or intolerance.
  • History of gastric reduction/bypass surgery.

Treatment and study plan

Oral amino acid tracer

Other

Whole body protein metabolism response to a dose of the supplement will be measured using a continuous oral sip-feeding (every 10 minutes) method of stable isotope tracer.

Primary outcomes

  1. Whole-body Protein Net Balance

    Time frame: 240 minutes

    grams of protein per 240 minutes as determined using stable isotope ingestion and blood analysis for said isotopes' concentrations.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2020
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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